Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07239440
NCT07239440Not yet recruitingPhase 2

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing BT-1 and BT-2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Dong-A ST Co., Ltd.1 site in 1 country288 target enrollmentStarted: November 1, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Interventions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
288
Locations
1
Primary Endpoint
HbA1c
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a multicenter, double-blind, active-controlled, randomized, parallel clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing BT-1 and BT-2 combination therapy in patients with type 2 diabetes who have inadequate glycemic control

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with type II diabetes mellitus aged 19 years or older
  • •Patients with fasting plasma glucose≤270mg/dL at the screening visit
  • •Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
  • •Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria

  • •Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
  • •Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
  • •Patients with severe infectious disease or severe traumatic systemic disorders
  • •Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
  • •Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption

Arms & Interventions

DA-2811

Experimental

DA-2811 + DA-2811-R2

Intervention: DA-2811 (Drug)

DA-2811-C

Experimental

DA-2811-C + DA-2811-R1

Intervention: DA-2811-C (Drug)

Outcomes

Primary Outcomes

HbA1c

Time Frame: Change from baseline at 12 weeks

Secondary Outcomes

  • HbA1c(Change from baseline at 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B PatientsHepatitis B
NCT05957380Dong-A ST Co., Ltd.120
Completed
Phase 4
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis BHBeAg-Positive Chronic Hepatitis B
NCT01913431Dong-A ST Co., Ltd.118
Completed
Phase 3
A Study to Evaluate the Efficacy and Safety of AD-203Acute GastritisChronic Gastritis
NCT04066530Addpharma Inc.475
Completed
Phase 4
A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.Acute GastritisChronic Gastritis
NCT01817556Dong-A ST Co., Ltd.258
Completed
Phase 4
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic ControlDiabetes Mellitus
NCT05743907Dong-A ST Co., Ltd.231